FDAClass IIApril 2, 2014

Mevion S250 recall

MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

Why was Mevion S250 recalled?

Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

S250-0001

Product
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Recalling firm
Mevion Medical Systems, Inc.
Quantity
1 unit
Distribution
USA Nationwide Distribution in the state of MO
Recall date
April 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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